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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03603652
Other study ID # NEU_2017_06
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 29, 2018
Est. completion date October 24, 2019

Study information

Verified date December 2020
Source Ethicon, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with medically inoperable primary soft tissue lesion of the lung will have transbronchial microwave ablation performed via transbronchial approach by an interventional pulmonologist or thoracic surgeon using CT imaging. Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging. Patients will be followed for one year following the ablation procedure for efficacy and safety.


Description:

Patients with medically inoperable primary soft tissue lesion of the lung (lesions less than or equal to 2cm and located in the outer two-thirds of the lung and not closer than 1cm to the pleura) will have transbronchial microwave ablation performed using CT imaging. All ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging. Patients will be followed for one year following the ablation procedure for efficacy and safety with specific follow-up visits at 30 days, 6 months, and 12 months post-ablation. A user experience questionnaire is completed by the treating physician to better understand the ease of the procedure.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date October 24, 2019
Est. primary completion date December 21, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Signed informed consent. 2. Patients = 18 years old. 3. Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification. 4. Willing to fulfill all follow-up visit requirements. 5. Medically inoperable primary soft tissue lesion of the lung or patient election not to have surgery. (Medically inoperable is defined per the following indicators: post op predictive FEV1 (forced expiratory volume in 1 second) < 40%; DLCO (diffusing capacity of the lung for carbon monoxide) < 40%; hypoxemia or hypercapnia diabetes with end-organ damage; or severe cerebral, cardiovascular, peripheral vascular disease, or chronic heart disease) 6. One soft tissue lesion = 2 cm in the outer two thirds of the lung and not closer than 1 cm to the pleura. (Outer two thirds of the lung is defined as peripheral beyond the segmental airway, past the segmental bronchi, such that proximal endobronchial soft tissue lesions are avoided; soft tissue lesions should not be contiguous with the pleura) 7. Radiographic resolution of pneumonia Exclusion Criteria: 1. Scheduled concurrent procedure for the target soft tissue lesion other than those that are lung related. 2. Pregnant or breastfeeding. 3. Physical or psychological condition that would impair study participation. 4. Patients with uncorrectable coagulography at time of screening. 5. Patient with implantable devices, including pacemakers or other electronic implants. 6. Prior pneumonectomy or bronchiectasis. 7. Severe neuromuscular disease. 8. Platelet count = 50,000/mm3. 9. ASA (American Society of Anesthesiologists) score of = 4. 10. Inability to tolerate anesthesia. 11. Expected survival less than 6 months. 12. Clinically significant hypertension. 13. Chronic ventilator support, which uses bi-level positive airway pressure (PAP). 14. Endobronchial soft tissue lesions proximal to the segmental airways

Study Design


Intervention

Device:
Microwave Ablation
Ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound to confirm disease staging.

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio
United States City of Hope Duarte California
United States New York Presbyterian-Weill Cornell Medicine New York New York
United States FirstHealth Moore Regional Hospital Pinehurst North Carolina
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Ethicon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients Whose Ablation Resulted in Technical Success Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CBCT imaging, immediately following the procedure. Immediately post-ablation (day 0)
Primary Number of Patients Whose Ablation Resulted in Technique Efficacy Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CT imaging, 30 days (+/- 7 days) after the first ablation procedure. 30 days post-ablation
Primary User Experience Survey (Part I) A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO. Immediately post-ablation
Primary User Experience Survey (Part II) A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the time it took to place the probe in a position that was ready for ablation. Immediately post-ablation
Primary User Experience Survey (Part III) A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many cone-beam CT (CBCT) scans were taken to place the probe such that it was ready for ablation. Immediately post-ablation
Primary User Experience Survey (Part IV) A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the distance of the tip of the probe to the center of the soft-tissue lesion (in mm) just before the ablation procedure was initiated. Immediately post-ablation
Primary User Experience Survey (Part V) A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many times the probe had to be repositioned to complete the ablation procedure. Immediately post-ablation
Secondary Number of Patients Who Experienced Target Lesion Recurrence Analyzed at 6 months and 1 year post-ablation via CT imaging measured at 6 months and 1 year post-ablation
Secondary Number of Patients Who Were Readmitted to the Hospital Any readmission to the hospital within 30 days of the ablation procedure. Within 30 days post-ablation
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